The multicenter, open-label THIO-101 trial has recently reported encouraging overall survival (OS) results. The first-of-its-kind trial is designed to evaluate THIO, a selective telomere-targeting agent for cancer cells, for its anti-tumor activity in patients with non-small cell lung cancer (NSCLC).
The data show a median OS of 16.9 months among the 22 enrolled participants, who received at least one dose of THIO, according to a press release from the trial sponsor, Maia Biotechnology.1 If confirmed, the results would represent a significant improvement compared with OS trends for standard-of-care (SOC) chemotherapy treatments, which typically range from 5 to 6 months in similar settings.
The ongoing THIO-101 trial is investigating the safety and efficacy of various doses of THIO in combination with a fixed dose of cemiplimab.2 In addition to evaluating safety and tolerability, the primary objectives include clinical efficacy, with overall response rate (ORR) serving as the key endpoint.
The study includes of three parts evaluating varying doses; however, the treatment regimen is consistent across each part. Enrolled participants begin treatment with THIO on days 1 to 3 of every 3-week cycle, followed by a fixed dose of cemiplimab on day 5 of each cycle.2 Participants may continue treatment until disease progression, withdrawal of consent, unacceptable toxicity, mortality, or upon completion of 1 year of treatment.2
Representatives from Maia Biotechnology have said these results may support an application for accelerated US Food and Drug Administration approval of THIO, depending on the final trial results. At the time of publication, the study completion date for the THIO-101 trial is October 31, 2026.
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